Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07277140

Impact of Iron Deficiency on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure

The relationship between iron deficiency (with or without anemia) and arrhythmic risk or ECG abnormalities in hospitalized HF patients remains poorly characterized. This is particularly relevant in settings where advanced iron therapies (e.g., intravenous iron supplementation) may not be readily available, and where simple clinical and electrocardiographic markers could help identify high-risk patients by evaluating the impact of iron deficiency (with and without anemia) arrhythmic events and resting ECG changes among patients admitted with heart failure. Understanding these associations may offer insights into the arrhythmogenic potential of iron deficiency and support the integration of iron status assessment into routine risk stratification and management of HF patients.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

Heart failure (HF) is a major global health problem, associated with high morbidity, mortality, and frequent hospitalizations. Beyond impaired cardiac function, HF is recognized as a systemic syndrome involving a wide range of metabolic, inflammatory, and hematologic disturbances that contribute to disease progression and adverse outcomes. Iron deficiency has emerged as a prevalent and clinically relevant comorbidity, affecting up to 55% of chronic HF patients and in up to 80% of those with AHF, even in the absence of overt anemia.

Iron plays a central role in cellular energy metabolism, oxidative phosphorylation, and mitochondrial function, processes that are especially critical in the metabolically demanding environment of the myocardium.

In patients with HF, anemia and iron deficiency has been associated with reduced exercise capacity, impaired quality of life, and increased risk of hospitalization, cardiovascular and all-cause mortality. While the impact of iron deficiency on functional status and survival has been widely investigated, its potential influence on cardiac electrical activity remains less well studied.

Emerging evidence suggests that iron deficiency may contribute to electrophysiological instability by promoting oxidative stress, altering repolarization, and impairing myocardial conduction. This could create a potential substrate for arrhythmias, which are a major cause of morbidity in patients with HF. Moreover, subtle resting electrocardiographic (ECG) abnormalities, such as QT prolongation, T-wave changes, or conduction delays, may reflect early electrical remodeling in the context of iron deficiency-even in the absence of clinically apparent arrhythmias

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adult patients (≥18 years) admitted to Assiut University Heart Hospital with a clinical diagnosis of heart failure (new-onset or decompensated).

Includes all ejection fraction categories (HFrEF, HFmrEF, and HFpEF).

Availability of 12-lead ECG, serum iron studies (ferritin, transferrin saturation, serum iron), and routine laboratory tests.

Willingness to participate and provide informed consent.

Exclusion criteria

Known history of primary electrical disorders (e.g., Brugada syndrome, Long QT syndrome, etc.).

Recent intravenous iron therapy or blood transfusion within the past 3 months.

End-stage renal disease requiring dialysis.

Known anemia due to non-iron-deficiency causes (e.g., hemolytic anemia, active malignancy, etc.).

Severe electrolyte imbalances (e.g., significant hypo-/hyperkalemia, hypo-/hypermagnesemia).

Active systemic infection, chronic inflammatory conditions, or recent chemotherapy.

severe valvular lesions

Treatment and study plan

Primary outcomes

  1. Incidence of anemia and iron deficiency in hospitalized patients with HF

    Time frame: through study completion, an average of 1 year

    The proportion of patients admitted with heart failure who are found to have anemia and/or iron deficiency during hospitalization. Anemia is defined according to WHO criteria (Hb <13 g/dL in men, <12 g/dL in women). Iron deficiency is defined as ferritin <100 ng/mL, or ferritin 100-299 ng/mL with transferrin saturation <20%.

  2. Incidence of arrhythmic events in hospitalized HF patients with and without iron deficiency possible

    Time frame: through study completion, an average of 1 year

    The proportion of hospitalized heart failure patients who experience arrhythmic events (such as atrial fibrillation, ventricular tachycardia, ventricular fibrillation, or clinically significant bradyarrhythmias) during admission. Patients will be categorized based on the presence or absence of iron deficiency (defined by ferritin <100 ng/mL, or ferritin 100-299 ng/mL with transferrin saturation <20%).

Secondary outcomes

  1. Resting ECG abnormalities in hospitalized HF patients with and without iron deficiency

    Time frame: through study completion, an average of 1 year

    The prevalence and types of resting ECG abnormalities (e.g., atrial fibrillation/flutter, QRS prolongation >120 ms, ST-T changes, pathological Q waves, left ventricular hypertrophy, bundle branch blocks, premature ventricular complexes) in hospitalized heart failure patients. Patients will be stratified according to the presence or absence of iron deficiency (defined as ferritin <100 ng/mL, or ferritin 100-299 ng/mL with transferrin saturation <20%).

  2. Correlation between iron parameters, anemia status, and resting electrophysiologic parameters on 12-lead ECG

    Time frame: through study completion, an average of 1 year

    This outcome evaluates the correlation between iron status indicators (serum ferritin, transferrin saturation, and serum iron levels) and anemia-defined according to WHO criteria (hemoglobin <13 g/dL in men, <12 g/dL in women)-with resting electrophysiologic parameters obtained from a standard 12-lead ECG.

    Each electrophysiologic parameter will be correlated separately with continuous iron and hemoglobin values

  3. Association between iron parameters (and anemia) and electrophysiologic parameters

    Time frame: through study completion, an average of 1 year

    Assessment of the relationship between iron status (ferritin, transferrin saturation, serum iron) and anemia (defined by WHO criteria: Hb <13 g/dL in men, <12 g/dL in women) with resting electrophysiologic parameters on 12-lead ECG. Parameters include:

    Rhythm: sinus rhythm, atrial fibrillation/flutter, ventricular arrhythmias

    Conduction: PR interval, QRS duration, bundle branch block

    Repolarization: QT/QTc interval, ST-T abnormalities

    Heart rate variability (if available)

    Patients will be stratified according to presence/absence of iron deficiency and anemia, and correlations will be examined between continuous iron parameters and ECG metrics.

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Abo Elhassan, Doctorate

CONTACT

[email protected]

+201115825387

Samar Mohamed Sadek, Master degree

CONTACT

[email protected]

+201055045413

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Impact of Iron Deficiency With and Without Anemia on Arrhythmic Events and Resting ECG Abnormalities in Patients Hospitalized With Heart Failure

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.